Not Yet RecruitingNot Applicable

SMART-IC-Pilot Study

China15 participantsStarted 2026-01-01

Plain-language summary

This small-scale, proof-of-concept pilot study aims to obtain preliminary evidence of msRDN procedural safety, feasibility, and short-term efficacy in patients with hypertension without medication therapy, to adequately plan an appropriate pivotal study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. Documented essential hypertension
✓. Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction
✓. Office BP ≥ 140/90 mmHg and \< 180/110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent
✓. Documented daytime ASBP ≥ 135 mmHg and \< 170 mmHg after 2-week washout
✓. Able and willing to comply with all study procedures and follow-up visit

Exclusion criteria

✕.Renal artery anatomy on either side, unsuitable for treatment:
✕. Main renal artery diameter \< 4 mm or \> 8 mm
✕. Main renal artery length \< 25 mm
✕. Single functioning kidney
✕. Presence of abnormal kidney (or secreting adrenal) tumors
✕. Renal artery with aneurysm
✕. Pre-existing renal stent or history of renal artery angioplasty
✕. Prior renal denervation procedure

What they're measuring

Change in daytime ASBP

Timeframe: From baseline to 2 months after RDN

Trial details

NCT IDNCT07336433

SponsorSyMap Medical (Suzhou), Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Jie WANG, MD,PHD

+8613511604566 jay329329@yahoo.com

View on ClinicalTrials.gov More Hypertensive Disease trials